PMID- 29574444
OWN - NLM
STAT- MEDLINE
DCOM- 20180913
LR  - 20181202
IS  - 2044-6055 (Electronic)
IS  - 2044-6055 (Linking)
VI  - 8
IP  - 3
DP  - 2018 Mar 23
TI  - Opioid use and harms associated with a sustained-release tapentadol formulation: 
      a postmarketing study protocol.
PG  - e020006
LID - 10.1136/bmjopen-2017-020006 [doi]
LID - e020006
AB  - INTRODUCTION: It has been argued that tapentadol may pharmacologically have lower 
      abuse potential than other pharmaceutical opioids currently available. However, 
      there has been no comprehensive triangulation of data regarding use and harms 
      associated with this formulation. A sustained-release formulation (SRF) of 
      tapentadol (Palexia) was released in Australia in 2011 and listed for public 
      subsidy in 2013. We summarise here the methods of a postmarketing study which 
      will measure postintroduction: (1) population level availability, (2) 
      extramedical use and diversion, (3) attractiveness for extramedical use and (4) 
      associated harms, of tapentadol compared against other pharmaceutical opioids. 
      METHODS AND ANALYSIS: We evaluated key sources on pharmaceutical use and harms in 
      Australia. This review indicateddata from four sources that disaggregate 
      pharmaceutical opioid formulations and capture tapentadol SRF could be 
      triangulated. These data sources comprised: (1) national pharmaceutical opioid 
      community sales data from 2011 to 2017, (2) national pharmaceutical opioid 
      poisonings reported to Poison Information Centres (PICs) from 2011 to 2017, (3) 
      number of vendors on online marketplaces listing pharmaceutical opioids for sale 
      and (4) data on pharmaceutical opioid extramedical use, attractiveness and harms 
      from interviews with people who regularly inject drugs in Australia. ETHICS AND 
      DISSEMINATION: Ethics approval is not required for use of pharmaceutical sales 
      data. Ethics approval has been obtained for use of national pharmaceutical opioid 
      poisonings reported to PICs (LNR/16/SCHN/44) and for use of online marketplace 
      data and interview data from people who inject drugs (HC12086). Key findings will 
      be published mid-2018 in a peer-reviewed academic journal, and presented at 
      various conferences and professional meetings.
CI  - (c) Article author(s) (or their employer(s) unless otherwise stated in the text of 
      the article) 2018. All rights reserved. No commercial use is permitted unless 
      otherwise expressly granted.
FAU - Peacock, Amy
AU  - Peacock A
AUID- ORCID: 0000-0002-5705-2026
AD  - National Drug and Alcohol Research Centre, University of New South Wales, Sydney, 
      New South Wales, Australia.
AD  - School of Medicine, University of Tasmania, Hobart, Tasmania, Australia.
FAU - Larance, Briony
AU  - Larance B
AD  - National Drug and Alcohol Research Centre, University of New South Wales, Sydney, 
      New South Wales, Australia.
FAU - Farrell, Michael
AU  - Farrell M
AD  - National Drug and Alcohol Research Centre, University of New South Wales, Sydney, 
      New South Wales, Australia.
FAU - Cairns, Rose
AU  - Cairns R
AD  - NSW Poisons Information Centre, The Children's Hospital at Westmead, Sydney, New 
      South Wales, Australia.
AD  - School of Medical Sciences, University of Sydney, Sydney, New South Wales, 
      Australia.
FAU - Buckley, Nicholas
AU  - Buckley N
AD  - NSW Poisons Information Centre, The Children's Hospital at Westmead, Sydney, New 
      South Wales, Australia.
AD  - School of Medical Sciences, University of Sydney, Sydney, New South Wales, 
      Australia.
FAU - Degenhardt, Louisa
AU  - Degenhardt L
AD  - National Drug and Alcohol Research Centre, University of New South Wales, Sydney, 
      New South Wales, Australia.
AD  - School of Population and Global Health, University of Melbourne, Melbourne, 
      Victoria, Australia.
AD  - Murdoch Children's Research Institute, Parkville, Victoria, Australia.
AD  - Department of Global Health, School of Public Health, University of Washington, 
      Seattle, Washington, USA.
LA  - eng
PT  - Journal Article
PT  - Research Support, Non-U.S. Gov't
DEP - 20180323
PL  - England
TA  - BMJ Open
JT  - BMJ open
JID - 101552874
RN  - 0 (Analgesics, Opioid)
RN  - 0 (Delayed-Action Preparations)
RN  - 0 (Phenols)
RN  - H8A007M585 (Tapentadol)
SB  - IM
MH  - Analgesics, Opioid/*economics/*poisoning
MH  - Australia/epidemiology
MH  - Commerce
MH  - Delayed-Action Preparations
MH  - Humans
MH  - Opioid-Related Disorders/epidemiology
MH  - Phenols/*therapeutic use
MH  - *Prescription Drug Diversion
MH  - *Product Surveillance, Postmarketing
MH  - Research Design
MH  - Tapentadol
PMC - PMC5875643
OTO - NOTNLM
OT  - harm
OT  - opioid
OT  - overdose
OT  - substance misuse
OT  - tamper
OT  - tapentadol
COIS- Competing interests: Some of the investigators have received 
      investigator-initiated untied educational grants from Reckitt Benckiser/Indivior 
      for studies of buprenorphine-naloxone (BL, LD), buprenorphine depot (BL, LD, MF), 
      naloxone (LD, MF), the development of an opioid-related behavior scale (BL, LD), 
      the pharmacogenetic predictors of treatment success (RA) and a study of 
      opioid-substitution therapy uptake among patients with chronic non-cancer pain 
      (BL, LD). Some of the investigators have also received investigator-initiated 
      untied educational grants from Mundipharma for postmarketing surveillance of a 
      tamper-resistant opioid formulation (AP, BL, LD, MF).
EDAT- 2018/03/27 06:00
MHDA- 2018/09/14 06:00
PMCR- 2018/03/23
CRDT- 2018/03/26 06:00
PHST- 2018/03/26 06:00 [entrez]
PHST- 2018/03/27 06:00 [pubmed]
PHST- 2018/09/14 06:00 [medline]
PHST- 2018/03/23 00:00 [pmc-release]
AID - bmjopen-2017-020006 [pii]
AID - 10.1136/bmjopen-2017-020006 [doi]
PST - epublish
SO  - BMJ Open. 2018 Mar 23;8(3):e020006. doi: 10.1136/bmjopen-2017-020006.